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Treatment of Newly Diagnosed High-Grade Gliomas in Patients Ages Greater Than or Equal to 3 and Less Than or Equal to 21 Years With a Phase II Irinotecan Window Followed by Radiation Therapy and Temozolomide


Phase 2
3 Years
21 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

Treatment of Newly Diagnosed High-Grade Gliomas in Patients Ages Greater Than or Equal to 3 and Less Than or Equal to 21 Years With a Phase II Irinotecan Window Followed by Radiation Therapy and Temozolomide


OBJECTIVES:

- Evaluate the efficacy of adjuvant irinotecan in children with newly diagnosed high
grade gliomas, brain stem glioma, or high risk grade II astrocytomas in terms of
complete and partial response rate in patients with postoperative measurable disease,
and in terms of the rate of freedom from recurrence in patients with no postoperative
measurable disease.

- Determine the 3 year overall and progression free survival rates in this patient
population when treated with adjuvant irinotecan followed by radiotherapy and
temozolomide.

- Assess the hematopoietic toxicity of temozolomide following local radiotherapy in this
patient population.

OUTLINE: Patients receive postoperative irinotecan IV over 60 minutes daily for 5 days on
weeks 1-2. Treatment repeats every 3 weeks for 2 courses. Following completion of irinotecan
and if appropriate, patients may undergo a second surgical resection.

Within 2 weeks following completion of chemotherapy or within 4 weeks of following a second
resection, patients receive image guided external beam radiotherapy 5 days per week for 6
weeks. Patients with residual tumor less than 3.5 cm in maximal diameter may undergo boost
radiosurgery.

At 4 weeks following completion of radiotherapy, patients receive oral temozolomide for 5
days. Treatment repeats every 3 weeks for 6 courses.

Patients are followed every 3 months for 2 years, then every 4 months for 3 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed newly diagnosed brain tumors

- Grade III or IV disease:

- Glioblastoma multiforme

- Anaplastic astrocytoma

- Anaplastic oligodendroglioma

- Anaplastic pleomorphic xanthoastrocytoma

- Anaplastic or malignant oligoastrocytoma

- Gemistocytic astrocytoma

- Malignant glioma

- Grade II glial tumors in unfavorable locations (i.e., imaging evidence of
gliomatosis cerebri and/or bithalamic involvement)

- Diffuse pontine gliomas with greater than 2/3 involvement of the pon

PATIENT CHARACTERISTICS:

Age:

- 3 to 21

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- WBC greater than 2,500/mm^3

- Platelet count greater than 100,000/mm^3

- Hemoglobin greater than 8.0 g/dL

Hepatic:

- Bilirubin no greater than 2.5 mg/dL

- SGOT/SGPT less than 5 times normal

Renal:

- Creatinine no greater than 2.0 mg/dL

Other:

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Prior corticosteroids allowed

Radiotherapy:

- No prior radiotherapy

Surgery:

- No more than 28 days since prior definitive surgery for brain tumor

Other:

- Concurrent anticonvulsants allowed

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Amar Gajjar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000067271

NCT ID:

NCT00004068

Start Date:

March 1999

Completion Date:

April 2003

Related Keywords:

  • Brain and Central Nervous System Tumors
  • childhood high-grade cerebral astrocytoma
  • childhood high-grade cerebellar astrocytoma
  • childhood oligodendroglioma
  • untreated childhood brain stem glioma
  • untreated childhood cerebellar astrocytoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Saint Jude Children's Research HospitalMemphis, Tennessee  38105-2794